Chemical & Data Integrity Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Position: Chemical & Data Integrity Specialist
Location:Nikom Amata City, Rayong

Report to:Assistant Lab Manager (Expat)

Main product:Peritoneal Dialysis (Dialysis Fluid)

Job Scope:Conduct specific chemical and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming raw materials to finished goods and Stability study, include environmental monitoring programs.Ensure operations in the laboratories are conducted in compliance with GLP, GMP and related data integrity requirements.

Job Responsibilities:

• Ensure compliance with testing SOPs and specifications. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab. 

• Monitor and ensure data integrity, good document practice and good laboratory practice are deployed throughout chemical and microbiological laboratory.

• Work closely with manufacturing team and participate in cross-functional meetings to support as necessary any activities to achieve the production plan and ensure timely release of product. 

• Coordinate and ensure lab equipment is calibrated and maintenance per the program. 

• Prepare and ensure the SOPs are updated and compliance with regulatory requirement and Baxter GQP/GQR  

• Assure compliance with company procedures. Prepare Lab readiness for any audits and visits. 

• Participate in Lab investigation (OOS) and supports in providing data for manufacturing investigation/NCA/CAPA 

• Participate and support in Change Control, validation activities. 

• Ensure a safe working environment for team. Escalate up to Manager if any risk of unsafety, non-compliance or any risk on the product. 

• Process SCAR supplier quality issues.

Qualifications:

• Bachelor’s degree in chemistry, or related science.

• 3 years’ experience in Quality Control, Analytical Laboratory in a pharmaceutical manufacturing environment.

• Good working knowledge in method validation, GMP, PIC/S, ISO 9001, ISO13485, Good Laboratory Practices, and ISO 17025 will be an advantage.

• Workable command of English and Computer literacy

• Flexibility in working hours​

• Good knowledge of GLP, GMP and data integrity requirements.Good understanding of the quality laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs.

• Sound knowledge in Statistical Analysis, cGMP, USP, PIC/S and GDP.

• Good understanding and experience in laboratory activities in the pharmaceutical or related industry.

Benefit & Welfares:

• Housing & Transportation Allowance

• Canteen, Provident Fund, Group Life/ Health Insurance

• Fixed Bonus, Variable Bonus

• Etc.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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